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The Role of Sedation Technique in EBUS-TBNA

Impact of Sedation Technique on the Diagnostic Accuracy of Endobronchial Ultrasound-guided Needle Aspiration (EBUS-TBNA)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02245295
Enrollment
232
Registered
2014-09-19
Start date
2014-01-31
Completion date
2014-06-30
Last updated
2016-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Bronchial endoscopy, ultrasound, EBUS, anesthesia, lung cancer, diagnosis including staging

Brief summary

There is a paucity of data concerning the impact of the sedation technique used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) on diagnostic accuracy. The aim of this retrospective study is to compare diagnostic accuracy of EBUS-TBNA in deep and moderate sedation, and to investigate other possible determinants of diagnostic accuracy in three lymph node locations (mediastinal, subcarinal, and hilar). The first consecutive patients at the University Hospital Zurich undergoing EBUS-TBNA for selective sampling in deep sedation are compared with the first consecutive patients in moderate sedation between 2006 and 2014. Diagnoses based on EBUS-TBNA were compared with those on surgical or radiological follow-up.

Detailed description

Between September, 2007 and January 31, 2014, all consecutive patients who undergo EBUS-TBNA at the University Hospital Zurich for selective assessment of enlarged (≥ 1 cm by CT or ultrasound) or suspected (enhanced fluorodeoxyglucose (FDG) activity in PET/CT) lymph nodes were enrolled. Demographic and clinical data, procedural reports and cytological findings were collected from medical records. Computed tomography (CT) or PET/CT scans were prospectively reviewed to gather the size and standardized uptake value (SUV) of FDG of each sampled lymph node. The cytological findings obtained with EBUS-TBNA were verified by histological examination, if a surgical biopsy (mediastinoscopy, thoracoscopy, or thoracotomy) was carried out following EBUS-TBNA, or alternatively by clinical and radiological follow-up data.

Interventions

PROCEDUREModerate Sedation for EBUS/TBNA

EBUS-TBNA was performed by one of the pulmonologists in moderate sedation (D.F., M.K.).

PROCEDUREGeneral anesthesia for EBUS/TBNA

EBUS-TBNA was performedin general anaesthesia by one of the thoracic surgeons (D.S., P.K.)

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* EBUS-TBNA

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy1-6 monthsSensitivity, negative predictive value

Secondary

MeasureTime frameDescription
Lymph node morphology1-6 monthsImpact of lymph node size on diagnostic accuracy
EBUS technique1-6 monthsImpact of EBUS technique (number of needle passes) on diagnostic accuracy

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026